MAraviroc In HIV/ HCV Coinfection and Liver fibrosis - maicol

• Conditions: HIV/ HCV Coinfection; MedDRA version: 9.1Level: LLTClassification code 10020443; MedDRA version: 9.1Level: PTClassification code 10019751

• Registration Number: EUCTR2009-010912-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patient with documented HIV-1/HCV (HCV-RNA detectable at quantitative assay) co-infection
2.Male or female ages > 18 years old
3.Patients who have voluntarily signed and dated the CI
4.Patients currently receiving a PI based HAART for at least 24 weeks based on Truvada plus Atazanavir 300 mg/ritonavir 100 mg QD
5.Patients taking the same ARV combination for at least 8 weeks before enrolment
6.Plasma HIV-RNA < 50 copies/ml in two consecutively examination in the previous 3 months. The last will be not older than 30 days
7.Any CD4 cell count are admitted
8.Patients can comply with the protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previously demonstrated clinically allergy or hypersensitivity to any excipients of the investigational medications
2. Ongoing treatment with immunomodulant drugs or growth factors (IL-2, G-CSF, GM-CSF)
3.Treatments with steroids within 4 weeks before the enrolment
4.Need to use pegIFN/RBV in the next two years
5.Patients with Child Pugh > A 6
6.Patients co-infected with HBV (HBsAg+)
7.Patients with autoimmune diagnosed disorders
8.Active drug abuse including alcohol or recreational drugs which, in the opinion of the investigator is expected to interfere with the patient?s ability to adhere to the study procedures and treatment regimen. Patients on a methadone program will be accepted if deemed appropriate by the investigator
9.Patients with a grade 3/4 laboratory abnormality defined by DAIDS grading table
10.Pregnant and breastfeeding women
11.Any active clinically significant diseases or life threatening diseases or findings during screening of medical history or physical examination that in the investigator?s opinion, would compromise the patient?s safety and outcome of the study
12.Use of disallowed concomitant therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified